Company: Agfa Healthcare NV
Date of Enforcement Report 10/17/2018
Class II:
PRODUCT
Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as PACS
Recall Number: Z-0101-2019
REASON
Adding an additional comparison study to the Clinical Side Bar in the Enterprise Imaging Diagnostics Desktop, can result in a change of the sort order of the studies in the Clinical Side Bar. The thumbnail images of the studies are no longer chronologically sorted with the most recent study at the top.
RECALLING FIRM/MANUFACTURER
Agfa Healthcare NV, Mortsel, Belgium on 8/3/2018
Voluntary: Firm Initiated
VOLUME OF PRODUCT IN COMMERCE
17
DISTRIBUTION
US distribution to states of: CA, FL, IN, LA, MN, PA, SC, TX, VA, and Puerto Rico and internationally to: Canada.